BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 1832417 · Received September 13, 2010

    Report

    Report Number
    2122870-2010-00522
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 11, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE LI HEPARIN PLASMA THAT WERE CENTRIFUGED FOR 5 MINUTES AT 3500 RPM. QC ON 08/13/2010 WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE 08/16/2010 AND PERFORMED VERIFICATION PROTOCOL, AND CARRYOVER TEST. THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. NO HARDWARE ISSUE WAS NOTED. A DEFINITIVE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY HIGH TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE AND ABOVE THE AMI CUT OFF GENERATED ON SYNCHRON LXI 725 CLINICAL SYSTEM FOR SEVEN PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. UPON REPEAT, THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1